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Date Added: Tue 15/06/2021

Pharmaceutical Regulatory Consultant

Morristown, NJ, US
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Company: CELLO HEALTH

Job Type: Permanent, FullTime

Job Description

Innovative Science Solutions, Inc. (ISS) a Cello Health business is a boutique scientific consulting company serving the worldwide pharmaceutical, biotechnology, and medical device industries. We are a team of scientists, regulatory strategists, and consultants providing a wide range of fully integrated scientific consulting services to industry and counsel. From FDA Advisory Committee meetings to complex litigation support, ISS delivers specialized solutions for business hurdles. For more information about our firm visit us at #removed#

You have high expectations for yourself and your career, so does ISS. Imagine what we will achieve together.

Responsibilities:

  • Identify and analyze clinical/regulatory information to support a variety of projects
  • Ensure accuracy and quality of work product deliverables
  • Create and execute regulatory strategies
  • Develop insightful and meaningful written and/or oral critical analysis of regulatory issues
  • Provide project oversight and ensure that projects stay within budget parameters
  • Communicate with clients to convey project status, interim reports and final project deliverables
  • Conceive, formulate and implement effective marketing initiatives designed to sell our companys services

Requirements

The ideal candidate is inquisitive, ambitious, hardworking and has a strong healthcare regulatory experience along with the following:

  • Advanced degree preferred in a life science or related field and 2-5 years relevant experience in regulatory affairs, medical affairs or clinical research
  • Proficient and comfortable with scientific/medical data and nomenclature
  • Ability to effectively communicate complex scientific and regulatory principles to non-scientists (as well as to scientists and healthcare professionals)
  • Relevant work experience; preferably in regulatory affairs and/or project management; previous experience with regulatory submissions, regulatory body meetings (e.g. FDA Advisory Committees) a plus
  • Proficient with Word, Outlook, Excel, and PowerPoint
  • Expert skills in internet searching and web browsing
  • Eagerness to work independently and in teams in a fast-paced environment
  • Excellent ability to interpret scientific charts, tables and figures
  • Passion for producing and presenting scientific data in oral presentations or written reports
  • Excellent communication skills
  • This position will require individuals to work in-person at our Morristown, NJ office

Benefits

We continually work to provide our employees with a competitive package, including:

  • 401(k) offering with Company match
  • Comprehensive health insurance plan options including UHC Choice 500 100% Employer paid for employee
  • Dental insurance option
  • Vision insurance option
  • Employee life insurance
  • Long & short term disability coverage
  • Paid Time Off
  • ISS Sponsored Tuition Reimbursement Program or Professional Development
  • Employee Assistance Program
  • Adoption Assistance Program

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